The Study Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'

Addpharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Gastric Ulcer

Treatments: Drug: AD-115A, AD-1151

Study type: Interventional

Funder types: Industry

Identifiers

NCT06902818

AD-115BE

Details and patient eligibility

About

The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.

Full description

A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state

Enrollment: 48 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
• Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Exclusion criteria

• Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1 : Reference Drug(AD-1151), Period 2 : Test Drug(A115A)

Treatment:

Drug: AD-115A, AD-1151

Sequence B

Experimental group

Description:

Period 1 : Test Drug(AD-115A), Period 2 : Reference Drug(AD-1151)

Treatment:

Drug: AD-115A, AD-1151